The aim of the study is to assess the safety profile of ADACEL vaccine in a small number of participants in China. Primary objective: * To describe the safety in terms of occurrence of serious adverse reactions and grade 3 adverse reactions after administration of Sanofi Pasteur's Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children. Secondary objective: * To describe the full reactogenicity profile after administration of sanofi pasteur's Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children.
Participants will be enrolled sequentially into the study groups to receive one dose of ADACEL at Day 0 (Visit 1) and will be followed-up for 28-35 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
0.5 mL, Intramuscular (IM)
0.5 mL, Intramuscular (IM)
Unnamed facility
Jiangsu, Jiangsu, China
Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling \>30 mm; Fever (temperature) \>39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity.
Time frame: Day 0 up to Day 28 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling \>30 mm; Fever (temperature) \>39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
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